After the FDA rescheduled its advisory panel meeting for Sarepta Therapeutics' (SRPT) Duchenne Muscular Dystrophy treatment eteplirsen, Piper Jaffray analyst Edward Tenthoff says he remains cautious on the drug's potential approval. The analyst highlights the "highly critical" briefing documents published on January 15. Although the FDA's review of the eteplirsen submission yielded a cleaner safety profile than BioMarin's (BMRN) drisaperson, the agency "was clearly not won over on efficacy," Tenthoff tells investors in a research note. He keeps a Neutral rating on Sarepta with a $15 price target. The stock is up 8%, or $1.10, to $14.97 in morning trading.

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Consensus for FY24 EPS is $1.65. Still sees FY24 revenue $2.7B-$2.8B, consensus $2.77B.

Reports Q1 revenue $649M, consensus $651.79M. "During the quarter, execution across our business led to double digit revenue growth, on a constant currency basis, and an 18% increase in non-GAAP diluted EPS. At the same time, we made rapid progress on advancing our strategic priorities for the year, including accelerating and maximizing the VOXZOGO opportunity, focusing R&D on the most productive assets, and increasing profitability," said CEO Alexander Hardy. "We were pleased with the outcome of our strategic R&D asset review, resulting in the acceleration and prioritization of the most potentially impactful medicines for patients...Quarterly results were driven by strong demand for VOXZOGO, the only approved treatment for children with achondroplasia, and solid contributions from our established enzyme products...Our registration-enabling plans with VOXZOGO in hypochondroplasia, and ongoing discussions with health authorities to align on development plans for idiopathic short stature and pathway conditions are on-track, with all three studies expected to begin enrollment this year."